LABETALOL HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for labetalol hydrochloride and what is the scope of patent protection?
Labetalol hydrochloride
is the generic ingredient in five branded drugs marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience, Schering, Sebela Ireland Ltd, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Eywa, Heritage Pharma, Rubicon, Sandoz, Teva, Unichem, Watson Labs, Zydus Pharms, and Alvogen, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for labetalol hydrochloride. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for LABETALOL HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 24 |
NDAs: | 30 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 39 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 69 |
Patent Applications: | 1,157 |
What excipients (inactive ingredients) are in LABETALOL HYDROCHLORIDE? | LABETALOL HYDROCHLORIDE excipients list |
DailyMed Link: | LABETALOL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for LABETALOL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Boston Medical Center | Phase 4 |
Marshall University | Phase 2 |
Loma Linda University | N/A |
Generic filers with tentative approvals for LABETALOL HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 5MG/ML | INJECTABLE;INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for LABETALOL HYDROCHLORIDE
Drug Class | beta-Adrenergic Blocker |
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for LABETALOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for LABETALOL HYDROCHLORIDE
US Patents and Regulatory Information for LABETALOL HYDROCHLORIDE
Expired US Patents for LABETALOL HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sebela Ireland Ltd | TRANDATE | labetalol hydrochloride | INJECTABLE;INJECTION | 019425-001 | Dec 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-004 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-004 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Schering | NORMODYNE | labetalol hydrochloride | INJECTABLE;INJECTION | 018686-001 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-003 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-001 | May 24, 1985 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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